Regulatory Quality and Pharmacovigilance Coordinator at Novo Nordisk

The RA, QA and PV Coordinator will be responsible for the following:

• Coordinate the printing and dispatch of Regulatory documents to the RA agents in Middle Africa
• Provide support with ordering valid RA documents required by tenders’ team (CPPs, GMPs) for the whole of Middle Africa and plan accordingly for those almost expiring. Keep a database for the same.
• Maintain database of RA agent contracts and Safety Data Exchange Agreements and keep track of payments to be made to the agents according to applications completed as per contracts.
• Assist with Minutes in Monthly RA, QA, PV and Logistics meetings.
• Clean-up of RA, QA and PV shared folders and archiving as per document retention policy and capturing all documents in the Wells Fargo Archive and local archive in the indexing tool.
• Coordinate the QC checks on customer contact logging, customer complaints, literature reviews and IO engage.
• Send the monthly reconciliation emails to SDEA partners (including encryption testing)
• Perform a review of HALO PV and ensure all requirements s are captured in the system.
• Come up with a campaign(s) to raise PV/QA awareness in the affiliate including PV safety day and QA day.
• Maintaining the Deviation & Change Request overview and keeping track of the timelines.
• Establish a Distributors Training plan and assist with the rollout of the new training platform.
• Assist in follow-up of SOP training Logs
• Assist in maintaining the overview of product release and keep track of destruction certificates.
• Assist in follow-up and archiving of the Biannual external requirements request/reconciliation from the distributors.

Qualifications

To qualify for the position, you must have:

• Bachelor’s degree preferably in Pharmacy or other related Pharmaceutical Sciences.
• An innovating mindset in a changing environment as the position requires very fast adaptation to changes and innovations in the industry.
• Problem solving and analytical skills and be capable of working in a culture of respect, teamwork and personal responsibility.
• Fluency in written and spoken English.